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New drug available for dyskinesia

Amantadine extended-release (ER) capsule (Gocovri) has been approved by the FDA for Parkinson disease (PD)-related dyskinesia. The drug was approved for patients with PD to control levodopa-induced dyskinesia, with or without concomitant dopaminergic medications. In clinical trials, amantadine ER was shown to reduce both dyskinesia and off-time in patients with PD who were receiving levodopa.


The long-acting treatment is taken once-daily at bedtime, allowing the plasma concentration of drug to increase slowly during sleep, and delivers consistently high levels of the drug in the morning with sustained concentrations throughout the day. Dosage adjustments are needed for patients with moderate or severe kidney impairment. Amantadine ER is contraindicated in patients with end-stage renal disease.


The most commonly observed adverse reactions are hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension.


New triple therapy inhaler approved for COPD

Fluticasone furoate (FF), umeclidinium (UMEC), and vilanterol (VI) inhalation powder (Trelegy Ellipta) has been approved by the FDA for the treatment of chronic obstructive pulmonary disease (COPD). The inhalation powder combines these three active molecules found in fluticasone furoate and vilanterol (Breo Ellipta) and umeclidinium (Incruse Ellipta) in the same inhaler and is the first once-daily triple medication for COPD to be marketed in the United States.


The inhalation powder is indicated for the long-term, once-daily maintenance treatment of patients with COPD (including chronic bronchitis and/or emphysema) who are on a fixed-dose combination of FF and VI for airflow obstruction; it also helps reduce exacerbations in patients whom additional treatment of airflow obstruction is desired. The inhalation powder is also used for patients who are already receiving UMEC and a fixed-dose combination of FF and VI. The inhaler is not indicated for relief of acute bronchospasm or the treatment of asthma.

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The most frequent adverse reactions reported by patients using the inhaler (incidence approximately 1%) included headache, back pain, dysgeusia, diarrhea, cough, oropharyngeal pain, and gastroenteritis. The combination inhaler carries the same risks as those of its individual components. Consult product labeling for full prescribing information, including a boxed warning concerning asthma-related death.


Nasal spray approved to treat nasal polyps

Fluticasone propionate nasal spray (Xhance) has been approved by the FDA for the treatment of nasal polyps in patients age 18 and older. It uses the exhalation delivery system, which delivers medication to deep areas in the nose by actuating the pump spray into one nostril while blowing into the mouthpiece of the device at the same time. Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity.

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Fluticasone propionate was evaluated in five clinical trials enrolling more than 1,500 adults, including two randomized, double-blind, placebo-controlled phase III pivotal trials in adults with nasal polyps and two open-label phase III clinical trials in adults with chronic sinusitis with and without nasal polyps. Most patients in both phase III pivotal clinical trials treated with fluticasone propionate experienced statistically significant reductions of both nasal congestion/obstruction at week 4 and total polyp grade at week 16, the coprimary end points.


The most commonly reported adverse reactions (in approximately 3% of patients) were epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis. The drug is expected to be available in the second quarter of 2018.